Balancing Benefits and Harms of COVID-19 Vaccines: Lessons from the Ongoing Mass Vaccination Campaign in Lombardy, Italy.

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age and sex. Methods. All citizens who are newly vaccinated from 27 December 2020 to 3 May 2021 are matched to unvaccinated controls according to age, sex, and vaccination date. Study outcomes include the events that are expected to be avoided by vaccination (i.e., hospitalization and death from COVID-19) and those that might be increased after vaccine inoculation (i.e., venous thromboembolism). The incidence rate ratios (IRR) of vaccinated and unvaccinated citizens are separately estimated within strata of sex, age category and vaccine type. When suitable, number needed to treat (NNT) and number needed to harm (NNH) are calculated to evaluate the balance between the benefits and harm of vaccines within each sex and age category. Results. In total, 2,351,883 citizens are included because they received at least one dose of vaccine (755,557 Oxford-AstraZeneca and 1,596,326 Pfizer/Moderna). A reduced incidence of COVID-19-related outcomes is observed with a lowered incidence rate ranging from 55% to 89% and NNT values ranging from 296 to 3977. Evidence of an augmented incidence of harm-related outcomes is observed only for women aged <50 years within 28 days after Oxford-AstraZeneca (being the corresponding adjusted IRR of 2.4, 95% CI 1.1-5.6, and NNH value of 23,207, 95% CI 10,274-89,707). Conclusions. A favourable balance between benefits and harms is observed in the current study, even among younger women who received Oxford-AstraZeneca.

The management of the Sars-CoV-2 pandemic in Italy, lessons earnt and reflections for the future.

BACKGROUND: Italy and especially Lombardy region was the first European Country hit by the covid 19 pandemic, without a proper preparedness plan. Italy's health-care service is a regionally based National Health Service (NHS) that provides universal coverage, largely free of charge at the point of service. Aim of this paper is to analyse the national and especially the regional strategies put in place to face the pandemic, focusing on the impact of the overlap of the political and health competences among national and regional authority. METHODS: Italian hygiene and preventive medicine society (SITI) realized a questionnaire submitted to National Institute for Health and regional stakeholder to investigate the response to the epidemic analysing the strategies and actions put in place both by the national and regional governments and the regional health authorities. RESULTS: The national survey highlighted several critical points in the management of the covid 19 pandemic in the different regional contexts such as lack of personnel in preventive departments and preparadness. CONCLUSIONS: Lessons learnt during the pandemic should shape the future of the Italian health service. (www.actabiomedica.it).

RiskRadar: development and pilot results of a technical intervention targeting combination prevention regarding HIV, viral hepatitis, sexually transmitted infections and tuberculosis.

BACKGROUND: The HIV pandemic impacts the lives of millions and despite the global coordinated response, innovative actions are still needed to end it. A major challenge is the added burden of coinfections such as viral hepatitis, tuberculosis and various sexually transmitted infections in terms of prevention, treatment and increased morbidity in individuals with HIV infection. A need for combination prevention strategies, tailored to high-risk key populations arises and technology-based interventions can be a valuable asset. The COVID-19 pandemic challenged the delivery of existing services and added stress to existing public health and clinical structures but also highlighted the potential of exploiting technical solutions for interventions regarding infectious diseases. In this paper we report the design process, results and evaluation findings from the pilots of 'RiskRadar'-a web and mobile application aiming to support combination prevention, testing and linkage to care for HIV, viral hepatitis, various sexually transmitted infections and tuberculosis. METHODS: RiskRadar was developed for the INTEGRATE Joint Action's aim to improve, adapt and pilot innovative digital tools for combination prevention. RiskRadar was designed iteratively using informed end-user-oriented approaches. Emphasis was placed on the Risk Calculator that enables users to assess their risk of exposure to one or more of the four disease areas, make informed decisions to seek testing or care and adjust their behaviours ultimately aiming to harm/risk reduction. RiskRadar has been piloted in three countries, namely Croatia, Italy and Lithuania. RESULTS: RiskRadar has been used 1347 times across all platforms so far. More than 90% of users have found RiskRadar useful and would use it again, especially the Risk Calculator component. Almost 49.25% are men and 29.85% are in the age group of 25-34. The application has scored 5.2/7 in the User Experience Questionnaire, where it is mainly described as "supportive" and "easy-to-use". The qualitative evaluation of RiskRadar also yielded positive feedback. CONCLUSIONS: Pilot results demonstrate above average satisfaction with RiskRadar and high user-reported usability scores, supporting the idea that technical interventions could significantly support combination prevention actions on Sexually Transmitted Infections.

Influenza Vaccination Campaign during the COVID-19 Pandemic: The Experience of a Research and Teaching Hospital in Milan.

BACKGROUND: During the COVID-19 pandemic, more than ever, optimal influenza vaccination coverage among healthcare workers (HCWs) is crucial to avoid absenteeism and disruption of health services, as well as in-hospital influenza outbreaks. The aim of this study is to analyze the 2020 influenza vaccination campaign, comparing it with the previous year's in a research and teaching hospital in Northern Italy. METHODS: adopting an approach based on combined strategies, three interventions were deployed: a promotional and educational campaign, vaccination delivery through both ad hoc and on-site ambulatories, and a gaming strategy. Personal data and professional categories were collected and analyzed using univariate logistic regression. Vaccinated HCWs were asked to fill in a questionnaire to describe their reasons for vaccination adherence. RESULTS: the vaccination coverage rate (VCR) was 43.1%, compared to 21.5% in 2019. The highest increase was registered among administrative staff (308.3%), while physicians represent the most vaccinated category (n = 600). Moreover, residents (prevalence ratio (PR): 1.12; 95% CI 1.04-1.20), as well as intensive care (PR: 1.44; 95% CI: 1.24-1.69) and newborn workers (PR: 1.41; 95% CI: 1.20-1.65) were, respectively, the categories most frequently vaccinated for the first time. CONCLUSION: the significant increase in vaccination coverage rate confirms the suitability of the combined strategy of delivering the flu vaccination campaign and represents a first step towards reaching WHO recommended vaccination rates.

CoViD-19, learning from the past: A wavelet and cross-correlation analysis of the epidemic dynamics looking to emergency calls and Twitter trends in Italian Lombardy region.

The first case of Coronavirus Disease 2019 in Italy was detected on February the 20th in Lombardy region. Since that date, Lombardy has been the most affected Italian region by the epidemic, and its healthcare system underwent a severe overload during the outbreak. From a public health point of view, therefore, it is fundamental to provide healthcare services with tools that can reveal possible new health system stress periods with a certain time anticipation, which is the main aim of the present study. Moreover, the sequence of law decrees to face the epidemic and the large amount of news generated in the population feelings of anxiety and suspicion. Considering this whole complex context, it is easily understandable how people "overcrowded" social media with messages dealing with the pandemic, and emergency numbers were overwhelmed by the calls. Thus, in order to find potential predictors of possible new health system overloads, we analysed data both from Twitter and emergency services comparing them to the daily infected time series at a regional level. Particularly, we performed a wavelet analysis in the time-frequency plane, to finely discriminate over time the anticipation capability of the considered potential predictors. In addition, a cross-correlation analysis has been performed to find a synthetic indicator of the time delay between the predictor and the infected time series. Our results show that Twitter data are more related to social and political dynamics, while the emergency calls trends can be further evaluated as a powerful tool to potentially forecast new stress periods. Since we analysed aggregated regional data, and taking into account also the huge geographical heterogeneity of the epidemic spread, a future perspective would be to conduct the same analysis on a more local basis.

Monitoring emergency calls and social networks for COVID-19 surveillance. To learn for the future: The outbreak experience of the Lombardia region in Italy.

On 18th February the first Italian case of Coronavirus Induced Disease 2019 (COVID19) due to secondary transmission outside China was identified in Codogno, Lombardia region. In the following days the number of cases started to rise not only in Lombardia but also in other Italian regions, although Lombardia remained and it is still the most affected region in Italy. At the moment, 234801 cases have been identified in Italy, out of which 90070 in Lombardia region. The (Severe Acute Respiratory Syndrome Coronavirus 2) SARS CoV 2 outbreak in Italy has been characterized by a massive spread of news coming from both official and unofficial sources leading what has been defined as infodemia, an over-abundance of information - some accurate and some not - that has made hard for people to find trustworthy sources and reliable guidance needed. Infodemia on SARS CoV 2 created the perfect field to build uncertainty in the population, which was scared and not prepared to face this outbreak. It is understandable how the rapid increase of the cases' number , the massive spread of news and the adoption of laws to face this outbreak led to a feeling of anxiety in the population whose everyday life changed very quickly. A way to assess the dynamic burden of social anxiety is a context analysis of major social networks activities over the Internet. To this aim Twitter represents a possible ideal tool since the focused role of the tweets according to the more urgent needs of information and communication rather than general aspects of social projection and debate as in the case of Facebook, which could provide slower responses for the fast individual and social context evolution dynamics.  Aim of the paper is to analyse the most common reasons for calling and outcomes. Furthermore, the joint analysis with Twitter trends related to emergency services might be useful to understand possible correlations with epidemic trends and predict new outbreaks.